CERASOOTHE CHX PLUS KET- chlorhexidine gluconate, ketoconazole spray

Ceraven by

Drug Labeling and Warnings

Ceraven by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

CeraSoothe CHX+KET

Antiseptic Topical Spray

Fragrance: Cucumber melon

A leave-on spray with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic activity on the skin. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin's natural immune system, and provide building blocks for renewed skin barrier integrity.

Active ingredients: Chlorhexidine gluconate 2%, ketoconazole 1%.

Inactive ingredients: Water, glycerin, polysorbate 20, propylene glycol, lactic acid, avena sativa (oat) kernal extract, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, methylisothiazolinone.

INDICATIONS & USAGE

Indications: For use on cats, dogs and horses with bacterial or fungal skin infections that are responsive to chlorhexidine or ketoconazole.

Directions for use: Apply 1 to 3 times per day for 2-3 weeks or as directed by your veterinarian. Part the fur and spray directly on the affected area of the skin. Gently smooth product on the skin to ensure full coverage. Wash hands after use.  Do not allow the animal to lick the treated area.

WARNINGS AND PRECAUTIONS

Cautions: For external use on cats, dogs and horses only. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

STORAGE AND HANDLING

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

QUESTIONS? (855) 724-3461

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

Inspired by veterinarians

CeraSoothe CHX+KET

Antiseptic Topical Spray

Fragrance: Cucumber melon

Chlorhexidine gluconate 2%

Ketoconazole 1%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6975-1

Net Contents: 8 fl oz (237 mL)

covetrus

INGREDIENTS AND APPEARANCE

CERASOOTHE  CHX PLUS KET
chlorhexidine gluconate, ketoconazole spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6975
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LACTIC ACID (UNII: 33X04XA5AT)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6975-1	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/16/2021

Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)